DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
Preliminary Amendment dated 06/17/2024 has been formally entered and amended claims 1-11 submitted with Preliminary Amendment dated 06/17/2024 are being examined on the merits
Specification
The disclosure is objected to because of the following informalities:
“…familiarity…” in page 1 line 25 needs to be corrected. A suggested correction is --familiality--.
“…treatment am electrostimulation” in page 3 line 11 needs to be corrected to -- treatment [[am]] and electrostimulation--.
“compo9nent” in page 11 line 6 needs to be changed to – compo[[9]]nent--.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 2 recites “the insertion” , “the passive rotation “needs to be corrected. A suggested correction is –[[the]] insertion– , -- [[the]] passive rotation—respectively in light of lack of any antecedent for the terms in current or preceding claims.
Each of claims 1-11 include reference characters which are enclosed within parentheses. The use of reference characters is considered as having no effect on the scope of the claims. Since the reference characters are not afforded patentable weight, the reference characters enclosed within parentheses should be deleted from the claims.
Claim 1 line 1 “Kit for improving the disturbances associated with the inflammation of adipose tissue, with the phlebolymphatic pathologies and for muscular rehabilitation” needs to be corrected. A suggested correction is – A kit [[Kit]] for improving [[the]] disturbances associated with [[the]] inflammation of adipose tissue, with [[the]] phlebolymphatic pathologies and for muscular rehabilitation – to correct typographical errors and in light of lack of any antecedent for the terms in current claim.
In each of claims 2-11 line 1 “Kit” needs to be corrected. A suggested correction is – The kit [[Kit]] – in light of its antecedent “Kit” in claim 1 line 1.
Claim 8 “said dedicated software is adapted to be configured by the operator at the start of the session by means of the computer terminal and in that said configuration occurs based on the data present in the memory and obtained from the preceding sessions of the patient and in that said dedicated software is adapted to be configured by the operator at the start of the session so as to set the value of the speed of the rotor … and the intensity of the pulses of the inducer device” needs to be corrected. A suggested correction is --said dedicated software is in a manner as to set the value of the speed of the rotor … and the intensity of the pulses of the inducer device-- [a] to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so as to” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required and [b] to fix informality arising from “adapted to be configured by” clause.
Claim 1 line 1-2 “Kit for improving the disturbances associated with the inflammation of adipose tissue, with the phlebolymphatic pathologies and for muscular rehabilitation comprising” needs to be corrected to --Kit for improving the disturbances associated with the inflammation of adipose tissue, with the phlebolymphatic pathologies and for muscular rehabilitation comprising:-- since the preamble in claim 1 lines 1-2 applies to all the limitations recited in the claim body.
Claim 1 “adapted to” encompassing limitations needs to be corrected. A suggested correction is to replace “adapted to “ with –configured to – to avoid potential intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 discussion especially regarding “Adapted to,” “Adapted for,” “Wherein,” and “Whereby” and Contingent Clauses). For example amend claim 1 lines 2-5 “with at least a screen … adapted to provide a communication interface between the user and the computer terminal comprised in said base element … and a system for electrical connection … that is wired or wireless, for the connection of said handpiece … to said base element…, in that said electrostimulator device is housed inside said base element …and is connected by means of an electric cable … to common electrodes … adapted to be positioned in proximity to the body area affected by the treatment with said handpiece” to – with at least a screen … [[adapted]] configured to provide a communication interface between the user and the computer terminal comprised in said base element … and a system for electrical connection … that is wired or wireless, for the connection of said handpiece … to said base element…, in that said electrostimulator device is housed inside said base element …and is connected by means of an electric cable … to common electrodes … [[adapted]] configured to be positioned in proximity to the body area affected by the treatment with said handpiece--.
In each of claims 2-6, 9-11 “adapted to” encompassing limitations needs to be corrected to by replacing adapted to “ with –configured to – to avoid potential intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 discussion especially regarding “Adapted to,” “Adapted for,” “Wherein,” and “Whereby” and Contingent Clauses). For example amend claim 2 “recess adapted to house a rotor … adapted to carry out work in a radial direction with respect to the axis of the access hole made on said head…in which said ring nut of the handle … comprises a central fitting system adapted to be inserted on a rotation mechanism…in which the head … comprises a flange … having one face adapted to allow the rotation of said head ring nut…in that the presence of said longitudinal internal channels … is adapted to confer to said balls … viscoelastic properties…in that on said cap … there is a pressure sensor … adapted to detect the pressure of the rotor … exerted by the balls…an encoder positioned on the rotary axis of the motor, adapted to detect the revolutions of the rotor … and to send the data to said electronic control unit” to --recess [[adapted]] configured to house a rotor … [[adapted]] configured to carry out work in a radial direction with respect to the axis of the access hole made on said head…in which said ring nut of the handle … comprises a central fitting system [[adapted]] configured to be inserted on a rotation mechanism…in which the head … comprises a flange … having one face [[adapted]] configured to allow the rotation of said head ring nut…in that the presence of said longitudinal internal channels … is [[adapted]] configured to confer to said balls … viscoelastic properties…in that on said cap … there is a pressure sensor … [[adapted]] configured to detect the pressure of the rotor … exerted by the balls…an encoder positioned on the rotary axis of the motor, [[adapted]] configured to detect the revolutions of the rotor … and to send the data to said electronic control unit--. Similar amendments are suggested for each of claims 3-6 and 9-11.
Claim 3 in lines 5-6 “at the time when they cyclically come into contact with the body tissue and in that the presence of the rigid balls” needs to be corrected. A suggested correction is -- at the time [[when]] while they cyclically come into contact with the body tissue and in that the presence of the rigid balls -- to avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met.
Claim 2 “in which the rotation of the rotor … is such to cause the passive rotation of each single ball … on itself each time” needs to be corrected. A suggested correction is – in which the rotor rotates in a manner as cause the passive rotation of each single ball … on itself each time-- to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding such to follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1-11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Each of claims 1-11 use the language “characterized by” which is indefinite in that it is unclear whether this is intended to be an inclusive or exclusive recitation, language such as comprising or consisting of should be used based upon what is intended.
Claim 1 recites “the user” in line 7, “the computer terminal” in line 7, “the body area” in line 12, “the dedicated outlet” in line 13-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “that this comes into contact with the tissue of the patient” which renders this claim unclear. More specifically, in the context used, it is unclear the term “this” is referencing what preceding structures.
Each of claim 1 and claim 11 recites “the treatment”. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “the axis” “the access hole”, “the lateral surface”, “the data”, “the rotation axis”, “the passive rotation”, “the cavity”, “the rotation”, “the/said computer terminal”, “the revolutions”, “said electrical connection system”, “the power supply”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “the body tissue”, “the muscle”, “said balls”, “said rotor”, “said longitudinal internal channels”. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “the mechanical resistance”, “said resistance”, “said display”, “said indicators”, “said pressure sensor”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites ”the data processing system”, “the resistance”, “the intensity of the pulses”, “the inducer device”, “the speed”, “the intensity”, “the pulses”, “the values”, “said pressure sensor”. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites ”the data processing system”, “the active resistance”, “the speed”, and “the frequency, duration, intensity”, “the electric pulse”, “the neighboring tissue”, “the body area”, “the muscle”, “the hypercompressive effect”, “said hypercompression”, “said synchronism”. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 “the self-adhesive electrodes” “the pre-gelled electrodes”. There is insufficient antecedent basis for this limitation in the claim.
Each of claim 3 and claim 6 recite at least one or more of “the muscle”. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites “the memory”, “the session”, “the preceding sessions”, “the data”, “the computer terminal”, “said dedicated software”, “the value”, “the speed”, “the intensity”, “the pulses”, “the inducer device”. There is insufficient antecedent basis for this limitation in the claim.
Each of claims 8-9 recite one of more instances of the limitation "the operator". There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “the session”, “the parameters”, “the computer terminal”, “the buttons”. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “the treatment session”, “the hypovascularization zones” “the thermographic data”, “said data”, “said computer terminal”, “the body areas”, “the dedicated software”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites “the damage”, “the detachment”, “the treatment”. There is insufficient antecedent basis for this limitation in the claim.
Each of claims 2, 4, 5, 8, 10 recite at least one or more instances of “the patient”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 in line 1 recites “Kit according to claim 1 characterized in that it comprises an elastic band” which renders this claim unclear. More specifically, in the context used, it is unclear the term “it” is referencing what preceding structures.
Claim 3 recites “said balls“, “said rotor” “said longitudinal internal channels” “the elastomeric balls”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 3 is being interpreted as being dependent upon claim 2 instead.
Claim 4 recites “the balls“, “the rotor” “the rigid balls” “said/the pressure sensor”, “the revolution sensor”, “said indicators”, “said display”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 4 is being interpreted as being dependent upon claim 3 instead.
Claim 5 recites “the rotor” “said pressure sensor”, “the revolution sensor”, “the inducer device” . There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 5 is being interpreted as being dependent upon claim 2 instead.
Claim 6 recites “the rotor”, “the row of rigid balls”, “said dedicated software”, “the active resistance”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 6 is being interpreted as being dependent upon claim 5 instead.
Claim 8 recites “the rotor”, “the inducer device”, “said dedicated software”, “the speed of the rotor” and “the intensity”, “the pulses of the inducer device”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 8 is being interpreted as being dependent upon claim 5 instead.
Claim 9 recites “the buttons”, “said dedicated software”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 9 is being interpreted as being dependent upon claim 5 instead.
Claim 10 recites “the dedicated software”. There is insufficient antecedent basis for this limitation in the claim. In the interest of furthering prosecution, claim 10 is being interpreted as being dependent upon claim 5 instead.
Claim 2 line 7 recites “at least four balls” which renders this claim unclear. More specifically, it is unclear as to whether claim 2 “at least four balls” is among “a plurality of balls” recited in claim 2 line 5 or in addition to that recited in claim 2 line 5.
Claim 2 in each of lines 8, 24, 25, 28, 34 recites “said balls” which renders this claim unclear. More specifically, it is unclear as to whether claim 2 “said balls” in each of lines 8, 24, 25, 28, 34 is the referencing claim 2 line 5 “a plurality of balls” and/or claim 2 line 7 “at least four balls”.
Claim 4 in line 6 recites “the aforesaid balls” which renders this claim unclear. More specifically, it is unclear as to whether claim 4 line 6 “the aforesaid balls” is referencing claim 4 line 3 “the rigid balls” and/or “the balls”.
Dependent claims 2-11 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-11 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. ]
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
More specifically, the following terms are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
Claims that invoke 35 U.S.C 112 (f)
Means term
Specification Support in instant application specification as-filed dated 06/17/2024
2
“isolating …support means”
At least fig. 5 “420”
2
“tightening means”
At least fig. 2 “410”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Interpretation
For reasons provided under section subtitiled “Claim Rejections - 35 USC § 112(b)”, claims 3-6, 8-10 are being interpreted as being directly and/or indirectly dependent upon claim 2.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schwarz et al. (Pub. No.: US 20200054890 A1, hereinafter referred to as “Schwarz”).
As per independent Claim 1, Schwarz discloses kit for improving the disturbances associated with the inflammation of adipose tissue, with the phlebolymphatic pathologies and for muscular rehabilitation (Schwarz, abstract, figures, [0055-0058], [0426], [0435] for example discloses relevant subject-matter. See Schwarz, [0002]) comprising a magnetotherapy device (Schwarz, fig. 4a, “13”, [0055]) with compressive microvibration (Schwarz, [0058]), an electrostimulator device (Schwarz, [0055]) and a digital thermographic camera (Schwarz, [0435]) characterized in that said magnetotherapy device with compressive microvibration comprises a base element provided with at least a recess suitable for housing at least a handpiece (Schwarz, fig. 4c, “13”, “18”), with at least a screen adapted to provide a communication interface between the user and the computer terminal comprised in said base element and a system for electrical connection that is wired or wireless (Schwarz, [0093]), for the connection of said handpiece to said base element (Schwarz, “105”, [0426]), in that said electrostimulator device is housed inside said base element (Schwarz, fig. 17-19b) and is connected by means of an electric cable to common electrodes (Schwarz, [0199-0200]) adapted to be positioned in proximity to the body area affected by the treatment with said handpiece (Schwarz, fig. 3b, 3c [0095]) and in which said electric cable by means of a common inlet plug is connected to the dedicated outlet made on said base element (Schwarz, [0093]) and in that said digital thermographic camera is connected by means of a common electric cable to the dedicated outlet made on said base element by means of an inlet plug (Schwarz, fig. 17-19b).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Prouza et al. (Pub. No.: US 20210146119 A1, hereinafter referred to as “Prouza”).
As per dependent Claim 7, Schwarz discloses Kit according to claim 1(see claim 1)
Schwarz does not explicitly disclose electrodes electrostimulator features.
However, in an analogous system for improving the disturbances associated with the inflammation of adipose tissue field of endeavor, Prouza discloses adipose tissue treatment system characterized in that said electrostimulator is connected to the electrodes and in that belonging to said electrodes are the self-adhesive electrodes, the pre-gelled electrodes and those constituting part of an electrostimulator band.(Prouza in at least abstract, [0042], [0096], [0147], [0207], [0220], [0240]. “soft tissue treatment comprises placing an applicator adjacent to a surface of a body part, the applicator including at least one electrode, providing a fastening mechanism fixing the applicator in contact with the body part, providing a radiofrequency energy by the at least one electrode causing a heating of the soft tissue, providing an electric current to the soft tissue by the at least one electrode causing a muscle contraction”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrostimulator used in system for improving the disturbances associated with the inflammation of adipose tissue as taught by Schwarz, in a manner that electrostimulator is connected to the electrodes and in that belonging to said electrodes are the self-adhesive electrodes, the pre-gelled electrodes and those constituting part of an electrostimulator band, as taught by Prouza as a matter of design choice (see MPEP 2144.04). A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing treatment energy to the patient's body in order to cause desired adipose tissue treatment effects (Prouza, [0042]).
As per dependent Claim 11, Schwarz discloses Kit according to claim 1(see claim 1)
Schwarz does not explicitly disclose electrode band features.
However, in an analogous system for improving the disturbances associated with the inflammation of adipose tissue field of endeavor, Prouza discloses adipose tissue treatment system characterized in that it comprises an elastic band adaptable to the body of any one patient (Prouza abstract, [0220] “fastening mechanism”), said band comprising said electrodes and being adapted to allow the treatment by said handpiece, avoiding the damage or the detachment of the electrodes themselves (Prouza in at least abstract, [0042], [0096], [0224]. “soft tissue treatment comprises … the applicator including at least one electrode, providing a fastening mechanism fixing the applicator in contact with the body part… providing an electric current to the soft tissue by the at least one electrode causing a muscle contraction”; [0224] “adhesive polymer…adhesive material”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrostimulator used in system for improving the disturbances associated with the inflammation of adipose tissue as taught by Schwarz, in a manner that electrostimulator is connected to the electrodes and in that belonging to said electrodes are the self-adhesive electrodes, the pre-gelled electrodes and those constituting part of an electrostimulator band, as taught by Prouza as a matter of design choice (see MPEP 2144.04). A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing treatment energy to the patient's body in order to cause desired adipose tissue treatment effects (Prouza, [0042]).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrostimulator coupling to the patient body used in system for improving the disturbances associated with the inflammation of adipose tissue as taught by Schwarz, in a manner that an elastic band adaptable to the body comprises electrodes and are adapted to allow the treatment by said handpiece, as taught by Prouza as a matter of design choice (see MPEP 2144.04). A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing fastening mechanism for fixing the electrode including applicator to the patient body part in order to ensure the electrode including treatment system stays in therapeutic contact with the body part (Prouza, abstract).
Contingently Allowable Subject-Matter
As per dependent Claim 2, dependent claim 2 would be contingently allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 3-6, 8-10, for reasons provided under section subtitiled “Claim Rejections - 35 USC § 112(b)”, claims 3-6, 8-10 are being properly interpreted as being directly and/or indirectly dependent upon claim 2. Thus, as per dependent claims 3-6, 8-10, claims 3-6, 8-10 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claims 2-6, 8-10, dependent claims 2-6, 8-10 each is also being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per dependent Claim 2, none of the prior art discloses a kit for improving the disturbances associated with the inflammation of adipose tissue… comprising a magnetotherapy device with compressive microvibration, an electrostimulator device and a digital thermographic camera in which said handpiece is constituted by a head, by a body and by a handle, in which in the head and in the body there is a recess adapted to house a rotor adapted to carry out work in a radial direction with respect to the axis of the access hole made on said head, in which said rotor has the form of a hollow cylinder, having on the lateral surface a plurality of balls that are free to rotate on themselves and forming rows by means of the insertion of pins in longitudinal central channels, in which each pin forms a row to which at least four balls belong and in which the rotation axis of the balls and of the rotor with that of insertion in the recess of the handpiece, in which said pins are constrained respectively to a head ring nut and to a ring nut of the handle, in which said ring nut of the handle comprises a central fitting system adapted to be inserted on a rotation mechanism constituting part of an electric motor housed within said handle, in which said electric motor is electrically connected… to an electrical connection cable connected to the computer terminal comprised in said base element, in which the rotation of the rotor is such to cause the passive rotation of each single ball on itself each time that this comes into contact with the tissue of the patient, by means of a rectangular opening made on said body, in which on the body, in a position opposite that of the rectangular opening , an interface …in which the head comprises a flange having one face adapted to allow the rotation of said head ring nut and having the other face constrained to a cap , in which said cap is connected to the head by means of at least a common pair of reversible connection systems … said balls are made of elastomeric material with an internal structure constituted by a plurality of longitudinal internal channels attained parallel around said longitudinal central channel , in that the presence of said longitudinal internal channels is adapted to confer to said balls viscoelastic properties that are defined and exploited for controllably absorbing the pressure exerted by the handpiece onto the tissue under treatment of the patient, in that in the cavity of said rotor there is an inducer device , constituted by at least a solenoid with cylindrical shape constrained at one end to a rotary bearing , in that said rotary bearing is constrained to said head ring nut , in that on said cap there is a pressure sensor adapted to detect the pressure of the rotor exerted by the balls on the tissue of the patient during the treatment, in that said pressure sensor is connected with an electronic control unit by means of a connection device , constituted by a connector provided with a plurality of pins, in that in proximity to the rotation mechanism there is a revolution sensor or an encoder positioned on the rotary axis of the motor, adapted to detect the revolutions of the rotor and to send the data to said electronic control unit , in that said electronic control unit is controlled by said computer terminal by means of a wiring system that passes by means of said electrical connection system with or without wires, and in that said electronic control unit is situated in proximity to and behind the interface and manages, by means of said connection device , the power supply to said inducer device including all of the limitations, features, combination and arrangement of features of their respective base claim 1 and any intervening claims.
Prior art US 20200054890 A1 to Schwarz et al. discloses device and methods using the influence of magnetic and induced electric field on biological structure. The magnetic field is time-varying and high powered therefore the method is based on a value of magnetic flux density sufficient to induce at least muscle contraction. The invention proposes further to combine the magnetic field with radiofrequency, light, mechanical or pressure source in order to provide an apparatus for improved treatment.
Prior art to US 20210146119 A1 to Prouza et al. discloses a method and system of a soft tissue treatment such as adipose tissue similar to that disclosed and claimed. More specifically, Prouza discloses system of a soft tissue treatment by placing an applicator adjacent to a surface of a body part, the applicator including at least one electrode, providing a fastening mechanism fixing the applicator in contact with the body part, providing a radiofrequency energy by the at least one electrode causing a heating of the soft tissue, providing an electric current to the soft tissue by the at least one electrode causing a muscle contraction, and controlling heating of the soft tissue by the radiofrequency energy and parameters of the electric current provided by the at least one electrode via a control unit.
Prior art US 20080249350 A1 to Marchitto et al. discloses methods, devices, and compositions for inducing changes in tissues for inducing alterations in tissues such as skin, for cosmetic purposes. More specifically, Marchitto discloses improving the cosmetic appearance of skin by controllably heating a superficial layer of skin thereby inducing acute tissue contraction or shrinkage and a wound response leading to the production of biomolecules, all of which result in improved cosmesis by incorporating a source of radiofrequency electrical energy coupled to coil, with requisite impedance matching network, thereby resulting in the production of an alternating magnetic field. When tissue is brought into proximity of the alternating magnetic field, inductive heating of the tissue results as a consequence of either or both of dipole formation and oscillation, and eddy current formation.
Prior art US 6155966 A to Parker discloses an apparatus and method for toning skin with a focused, coherent electromagnetic field. More specifically, Parker discloses apparatus and method for toning tissue and particularly skin with a focused, coherent electromagnetic field that employs a housing, a user-accessible switch positioned on the housing, and electronics and an electromagnet assembly positioned within the housing. The electromagnet assembly includes a static magnet and an electromagnet which are assembled relative to each other and positioned within the housing such that negative magnetic poles of the static magnet and the electromagnet both face outwardly from an end portion of the housing. The electronics provide a periodic current depending upon a setting of the switch. The electromagnet assembly generates a focused, coherent electromagnetic field in response to the periodic current.
Prior art US 20150157873 A1 to Sokolowski discloses a device and a method for repetitive nerve stimulation in order to break down fat tissue by means of inductive magnetic fields, which device and method permit easy patient-related adjustability and control in order to reduce fat tissue in defined body regions, such as the abdomen, buttocks, or thighs, in a targeted manner and without body contact using the effect of the stimulation of muscle contractions by contactless induction of electric fields by means of pulsed magnetic fields in the tissue. By influencing the electric currents, pulsating magnetic fields are also able to stimulate ion transport and measurably increase metabolism.
Prior art US 20170182334 A1 to Altshuler et al. discloses method and apparatus for treating tissue in a region at depth while protecting non-targeted tissue by cyclically applying cooling to the patients skin and by applying radiation to the patient's skin above the region to selectively heat tissue during and/or after cooling is applied. Treatment may also be enhanced by applying mechanical, acoustic or electrical stimulation to the region.
Prior art to US 20090171266 A1 to Harris discloses a system for combination therapy for producing lysis of adipose tissue that includes a transducer adapted to apply focused ultrasonic energy to said adipose tissue and at least one additional unit adapted to provide a therapeutic procedure to said adipose tissue or surrounding tissue.
Prior art US 20070293849 A1 to Hennings et al. discloses a treatment of cellulite and adipose tissue via method and apparatus that will alter the fibrous strands in the fatty layers of the skin to reduce the appearance of cellulite and adipose tissue. Electromagnetic energy is used to selectively shrink or alternatively photoacoustically ablate the collagen in the constricting bands of connective tissue that causes the dimpled appearance of cellulite and adipose tissue while avoiding damage to the surrounding fatty cells.
Prior art US 20060259102 A1 to Slatkine discloses method and apparatus for enhancing the absorption of light in targeted skin structures. After applying a vacuum to a vacuum chamber placed on a skin target and pressure modulating the applied vacuum, the concentration of blood and/or blood vessels is increased within a predetermined depth below the skin surface of the skin target. Optical energy associated with light directed in a direction substantially normal to a skin surface adjoining the skin target is absorbed within the predetermined depth.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in dependent device claim 2 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 3-6, 8-10, dependent claims 3-6, 8-10would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20050261584 A1 to Eshel discloses methodology and system for treating or breaking down cellulite and fat similar to that disclosed. More specifically, method and system for treating or breaking down cellulite and fat including directing ultrasonic energy at a multiplicity of target volumes within the region, which target volumes contain cellulite and fat, thereby to selectively lyse or induce apoptosis in the cellulite and fat in the target volumes and generally not lyse or not induce apoptosis in non-cellulite and non-fat tissue in the target volumes and computerized tracking of the multiplicity of target volumes notwithstanding movement of the body.
Prior art US 20030220674 A1 to Anderson et al. discloses methods for use in the selective disruption of lipid-rich cells similar to that disclosed.. More specifically, a device for use in carrying out the methods for selective disruption of lipid-rich cells by controlled cooling.
Prior art US 20070060989 A1 to Deem et al. discloses methods and apparatus are provided for disruption/destruction of subcutaneous structures in a mammalian body for the treatment of skin irregularities, and other disorders such as excess adipose tissue, cellulite similar to that disclosed. More specifically, methods and apparatus are provided for disruption/destruction of subcutaneous structures in a mammalian body for the treatment of skin irregularities, and other disorders such as excess adipose tissue, cellulite, and scarring.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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